Communications system for an implantable device and a drug dispenser

ABSTRACT

A closed loop system for monitoring drug dose, intake and effectiveness includes a pill dispenser in data communications with at least one implantable medical device. The system is preferably implemented in a web-enabled environment in which a remote data center communicates with the implantable devices (IMDs) in a patient via a programmer or the pill dispenser. Th data center includes high speed computers and databases relating to patient history and device information. A physician or clinician may access the remote data center to review and monitor the IMDs remotely. More specifically, the IMDs are adapted to chronically monitor the pill dispenser to thereby log and document drug dose, patient compliance with prescriptive regimens and as well to monitor drug efficacy in the patient. The system further provides a dynamic drug management system, compatible with a web-enabled interactive data communication environment, that accurately monitors dose and specific drug effectiveness in a patient to enhance patient care.

This is a continuation of application Ser. No. 09/475,709, filed Dec.30, 1999, now U.S. Pat. No. 6,471,645.

THE FIELD OF THE INVENTION

The present invention relates to implantable medical devices (IMDs).Specifically, the invention pertains to a remote bi-directionalcommunications between the IMDs and a drug dispenser. More specificallythe invention pertains to a closed loop system in which the IMDs monitorand determine the presence of a specific drug dose in the patient's bodyto send instructions to the drug dispenser or an interface medical unit(IMU) to implement a drug management scheme based on the monitored data.More specifically, the invention provides a dynamic drug managementsystem in which the drug dose is chronically monitored by the IMDs toenhance drug effectiveness and as well monitor patient compliance withrecommended drug administration regimen. The invention preferablyutilizes a robust communication system integrated with a remote expertdata center in a web-enabled environment to transmit the IMDs' data to aphysician for evaluation and review thereby enhancing the delivery oftherapy and clinical care remotely.

BACKGROUND OF THE INVENTION

A technology-based health care system that fully integrates thetechnical and social aspects of patient care and therapy should be ableto flawlessly connect the client with care providers irrespective ofseparation distance or location of the participants. While clinicianswill continue to treat patients in accordance with accepted modernmedical practice, developments in communications technology are makingit ever more possible to provide a seamless system of remote patientdiagnostics, care and medical services in a time and place independentmanner.

Prior art methods of clinical services are generally limited toin-hospital operations. For example, if a physician needs to review theperformance parameters of an implantable device in a patient, it islikely that the patient has to go to the clinic. Further, if the medicalconditions of a patient with an implantable device warrant a continuousmonitoring or adjustment of the device, the patient would have to stayin a hospital indefinitely. Further, if the patient with the IMDs istaking a drug, it is often clinically prudent to monitor the dose andits impact on the patient and, as well, on the IMDs. Such a continuedtreatment plan poses both economic and social problems. Under theexemplary scenario, as the segment of the population with implantedmedical devices increases many more hospitals/clinics including servicepersonnel will be needed to provide in-hospital service for thepatients, thus escalating the cost of healthcare. Additionally thepatients will be unduly restricted and inconvenienced by the need toeither stay in the hospital or make very frequent visits to a clinic.

Yet another condition of the prior art practice requires that a patientvisit a clinic center for occasional retrieval of data from theimplanted device to assess the operations of the device and gatherpatient history for both clinical and research purposes. Such data isacquired by having the patient in a hospital/clinic to down load thestored data from the implantable medical device. Depending on thefrequency of data collection this procedure may pose serious difficultyand inconvenience for patients who live in rural areas or have limitedmobility. Similarly, in the event a need arises to upgrade the softwareof an implantable medical device, the patient will be required to comeinto the clinic or hospital to have the upgrade installed. Further, inmedical practice it is an industry-wide standard to keep an accuraterecord of past and contemporaneous procedures relating to an IMD uplinkwith, for example, a programmer. It is required that the report containthe identification of all the medical devices involved in anyinteractive procedure. Specifically, all peripheral and major devicesthat are used in down linking to the IMD need to be reported. Currently,such procedures are manually reported and require an operator or amedical person to diligently enter data during each procedure. One ofthe limitations of the problems with the reporting procedures is thefact that it is error prone and requires rechecking of the data toverify accuracy.

A further limitation of the prior art relates to the management ofmultiple medical devices in a single patient. Advances in modern patienttherapy and treatment have made it possible to implant a number ofdevices in a patient. For example, IMDs such as a defibrillator or apacer, a neural implant, a drug pump, a separate physiologic monitor andvarious other IMDs may be implanted in a single patient. To successfullymanage the operations and assess the performance of each device in apatient with multi-implants requires a continuous update and monitoringof the devices. As is often the case, patients with multi-implantedmedical devices may take a variety of medications. It is thereforenecessary to monitor drug intake and its effect on the oprerational andfunctional parameters of the IMDs. More importantly, chronic monitoringof drug intake and its effect on the physiological and clinicalconditions of the patient enables a proactive intervention to change thecourse of an otherwise serious medical condition. Thus, there is a needto monitor drug delivery and effectiveness via IMDs.

Accordingly it is vital to have a drug dispenser unit that wouldestablish a communication system with IMDs. The unique position of IMDsenables a real-time assessment of physiological conditions which maychange or indicate a measurable variance due to drug dose and delivery.IMDs could be adapted to provide measurements relating to thephysiological impact of drug therapy. Further, IMDs could be adapted toprovide a quick evaluation of the effectiveness of a drug to support aclinical decision as to whether a given dose is a prudent course oftherapy.

The proliferation of patients with multi-implant medical devicesworldwide has made it imperative to provide remote services to the IMDsand timely clinical care to the patient. Frequent use of programmers tocommunicate with the IMDs and provide various remote services,consistent with co-pending applications titled “Apparatus and Method forRemote Troubleshooting, Maintenance and Upgrade of Implantable DeviceSystems,” filed on Oct. 26, 1999, Ser. No. 09/426,741; “Tactile Feedbackfor Indicating Validity of Communication Link with an ImplantableMedical Device,” filed Oct. 29, 1999, Ser. No. 09/430,708; “Apparatusand Method for Automated Invoicing of Medical Device Systems,” filedOct. 29, 1999, Ser. No. 09/430,208; “Apparatus and Method for RemoteSelf-Identification of Components in Medical Device Systems,” filed Oct.29, 1999, Ser. No. 09/429,956; “Apparatus and Method to Automate RemoteSoftware Updates of Medical Device Systems,” filed Oct. 29, 1999, Ser.No. 09/429,960; “Method and Apparatus to Secure Data Transfer FromMedical Device Systems,” filed Nov. 2, 1999, Ser. No. 09/431,881;“Implantable Medical Device Programming Apparatus Having An AuxiliaryComponent Storage Compartment,” filed Nov. 4, 1999, Ser. No. 09/433,477;which are all incorporated by reference herein in their entirety, hasbecome an important aspect of patient care. Thus, in light of thereferenced disclosures, communication with IMDs enhances the delivery oftherapy and clinical care in real time. Specifically, as the number ofpatients with IMDs increases globally, the need to manage drug deliveryand intake remotely becomes an economic imperative. Further, IMDs whichare communicable and operable in a web-enabled environment, ascontemplated by the cited disclosures hereinabove, provide a uniqueplatform to assess the efficacy of drugs and the compliance of patientswith prescribed regimens. Further, it is vital to have a drug dispenserthat is adapted to have data communications with the IMDs and other datacenters to support the remote patient management system contemplated bythe present invention.

The prior art provides various types of remote sensing andcommunications with an implanted medical device. One such system is, forexample, disclosed in Funke, U.S. Pat. No. 4,987,897 issued Jan. 29,1991. This patent discloses a system that is at least partiallyimplanted into a living body with a minimum of two implanted devicesinterconnected by a communication transmission channel. The inventionfurther discloses wireless communications between an external medicaldevice/programmer and the implanted devices.

One of the limitations of the system disclosed in the Funke patentincludes the lack of communication between the implanted devices,including the programmer, with a remote clinical station. If, forexample, any assessment, monitoring or maintenance is required to beperformed on the IMD the patient will have to go to the remote clinicstation or the programmer device needs to be brought to the patient'slocation. More significantly, the operational worthiness and integrityof the programmer cannot be evaluated remotely thus making it unreliableover time as it interacts with the IMD. Further, in light of the presentinvetion, the Funke patent does neither suggest nor disclose thecommunications system between the IMD and a drug dispenser to monitorand assess in the effectiveness of the dose based on the physiologicalstatus of the patient.

Yet another example of drug management based on smart drug dispenserunits is disclosed by Martindale et al in U.S. Pat. No. 4,360,125 issuedon Nov. 23, 1982. In the disclosure, a medication dispenser in whichmedication to be dispensed is housed including a member operable toallow medication access. The dispenser provides a medication alertsignal at preselected times in accordance with a desired medicationregimen. A medication access signal is provided when medication accessis obtained. Data representative of the relative timing between amedication alert signal and a medication access signal is written intoreadable memory whereby that data is available to a physician forevaluation. In the preferred embodiment, the data is representative ofthe time of occurrence of each medication alert signal and medicationaccess signal. The interval between medication alert signals isselectively alterable.

Further, examples of drug management based on smart drug dispensers aredisclosed in U.S. Pat. Nos. 4,768,176; 4,768,177; 5,200,891; 5,642,731;5,752,235 and 5,954,641 all to Kehr et al. Generally all the patentsrelate to a drug dispensing system with various alert features tomonitor and manage the administration of medication and medicaltreatment regimens. None of these patents suggest or disclose acommunication between the drug dispensing systems and an IMD.

Yet another prior art reference provides a multi-module medicationdelivery system as disclosed by Fischell in U.S. Pat. No. 4,494,950issued Jan. 22, 1985. The disclosure relates to a system consisting amultiplicity of separate modules that collectively perform a usefulbiomedical purpose. The modules communicate with each other without theuse of interconnecting wires. All the modules may be installedintracorporeal or mounted extracorporeal to the patient. In thealternate, some modules may be intracorporeal with others beingextracorporeal. Signals are sent from one module to the other byelectromagnetic waves. Physiologic sensor measurements sent from a firstmodule cause a second module to perform some function in a closed loopmanner. One extracorporeal module can provide electrical power to anintracorporeal module to operate a data transfer unit for transferringdata to the external module.

The Fischell disclosure provides modular communication and cooperationbetween various medication delivery systems. However, the disclosuredoes not provide an external pill dispenser which is in wirelesscommunications with IMDs. Further, the system does neither teach nordisclose an external programmer for telemetrically interacting with thepill dispenser.

Accordingly, it would be advantageous to provide a pill dispenser thatcommunicates with IMDs to implement an effective drug management system.Yet another desirable advantage would be to provide a high speedcommunications scheme to enable the transmission of high fidelity sound,video and data to advance and implement efficient remote drug managementof a clinical/therapy system via a programmer thereby enhancing patientclinical care. As discussed herein below, the present invention providesthese and other desirable advantages.

SUMMARY OF THE INVENTION

The present invention generally relates to a communications scheme inwhich a remote web-based expert data center interacts with a patienthaving one or more implantable medical devices (IMDs) via an associatedexternal medical device, preferably a programmer, located in closeproximity to the IMDs. The IMDs are adapted to communicate with a pilldispenser to monitor and log pill deposition and effectiveness. Some ofthe most significant advantages of the invention include the use ofvarious communications media between the remote web-based expert datacenter and the programmer to remotely exchange clinically significantinformation and ultimately effect real-time drug intake and prescriptivechanges as needed.

One of the many aspects of the present invention includes a real-timeaccess of a programmer or a pill dispenser to a remote web-based expertdata center, via a communication network, which includes the Internet.The operative structure of the invention includes the remote web-basedexpert data center, in which an expert system is maintained, having abi-directional real-time data, sound and video communications with theprogrammer via a broad range of communication link systems. Theprogrammer is in turn in telemetric communications with the IMDs suchthat the IMDs may uplink to the programmer or the programmer may downlink to the IMDs, as needed.

Yet another feature of the invention includes a communications schemethat provides a highly integrated and efficient method and structure ofclinical information management in which various networks such asCommunity access Television, Local area Network (LAN), a wide areanetwork (WAN) Integrated Services Digital Network (ISDN), the PublicSwitched telephone Network (PSTN), the Internet, a wireless network, anasynchronous transfer mode (ATM) network, a laser wave network,satellite, mobile and other similar networks are implemented to transfervoice, data and video between the remote data center and a programmer.In the preferred embodiment, wireless communications systems, a modemand laser wave systems are illustrated as examples only and should beviewed without limiting the invention to these types of communicationsalone. Further, in the interest of simplicity, the applicants refer tothe various communications system, in relevant parts, as acommunications system. However, it should be noted that thecommunication systems, in the context of this invention, areinterchangeable and may relate to various schemes of cable, fiberoptics, microwave, radio, laser and similar communications or anypractical combinations thereof.

Some of the distinguishing features of the present invention include theuse of a robust web-based expert data center to collect drug therapyinformation based on data communication between the IMDs, the pilldispenser and the programmer. Specifcally the invention enables remoteevaluation of drug performance in a patient. Although the presentinvention focuses on the remote real-time monitoring and management ofdrug therapy information, the system could advantageously be used tomonitor clinical trials of drugs or collect clinical data relating todrug interaction or physiological impact of various doses on thepatient.

Yet one of the other distinguishing features of the invention includesthe use a highly flexible and adaptable communications scheme to promotecontinuous and real-time communications between a remote expert datacenter, a programmer and a pill dispenser associated with a plurality ofIMDs. The IMDs are structured to share information intracorporeally andmay interact with the programmer or the pill dispenser as a unit.Specifically, the IMDs either jointly or severally can be interrogatedto implement or extract clinical information as required. In otherwords, all of the IMDs may be accessed via one IMD or, in the alternate,each one of the IMDs may be accessed individually. The informationcollected in this manner may be transferred to the data center via theprogrammer or pill dispenser by up linking the IMDs as needed.

The invention provides significant compatibility and scalability toother web-based applications such as telemedicine and emerging web-basedtechnologies such as tele-immersion. For example, the system may beadapted to webtop applications in which a webtop unit may be used touplink the patient to a remote data center for drug information exchangebetween the IMDs and the remote expert data center. In these and otherweb-based similar applications the data collected, in the manner andsubstance of the present invention, may be used as a preliminaryscreening to identify the need for further intervention using theadvanced web technologies.

More significantly, the invention provides a system and method toremotely monitor drug effectiveness in a patient. Further, the inventionenables a chronic evaluation of drugs in a patient on real time basis.The significance of this method includes the fact that the datacollected in this manner could be used to influence the course of drugtherapy.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be appreciated as the same becomes betterunderstood by reference to the following detailed description of thepreferred embodiment of the invention when considered in connection withthe accompanying drawings, in which like numbered reference numbersdesignate like parts throughout the figures thereof, and wherein:

FIG. 1 is a simplified schematic diagram of major uplink and downlinktelemetry communications between a remote clinical station, a programmerand a plurality of implantable medical devices (IMDs);

FIG. 2 is a block diagram representing the major components of an IMD;

FIG. 3A is a block diagram presenting the major components of aprogrammer;

FIG. 3B is a block diagram representing a laser transceiver for highspeed transmission of voice, video and other data;

FIGS. 4A, 4B and 4C illustrate a perspective view, a side view and aschematic for the drug dispensing unit or interface medical unit,respectively; and

FIG. 5 is a block diagram representing the major data centers and thecommunication scheme according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a simplified schematic of the major components of the presentinvention. Specifically, a bi-directional wireless communications systembetween programmer 20, pill dispenser 20′ and a number of implantablemedical devices (IMDS) represented by IMD 10, IMD 10′ and IMD 10″ isshown. The IMDs are implanted in patient 12 beneath the skin or muscle.The IMDs are electrically coupled to electrodes 18, 3 0, and 3 6respectively in a manner known in the art. IMD 10 contains amicroprocessor for timing, sensing and pacing functions consistent withpreset programmed functions. Similarly, IMDs 10′ and 10″ aremicroprocessor-based to provide timing and sensing functions to executethe clinical functions for which they are employed. For example, IMD 10′could provide neural stimulation to the brain via electrode 30 and IMD10″ may function as a drug delivery system that is controlled byelectrode 36. The various functions of the IMDs are coordinated usingwireless telemetry. Wireless links 42, 44 and 46 jointly and severallycouple IMDs 10, 10′ and 10″ such that programmer 20 may transmitcommands or data to any or all the of IMDs via one of telemetry antennas28, 32 and 38. This structure provides a highly flexible and economicalwireless communications system between the IMDS. Further, the structureprovides a redundant communications system, which enables access to anyone of a multiplicity of IMDs in the event of a malfunction of one ortwo of antennas 28, 32 and 38.

Programming commands or data are transmitted from programmer 20 to IMDs10, 10′ and 10″via external RF telemetry antenna 24. Telemetry antenna24 may be an RF head or equivalent. Antenna 24 may be located onprogrammer 20 externally on the case or housing. Telemetry antenna 24 isgenerally telescoping and may be adjustable on the case of programmer20. Both programmer 20 and pill dispenser 20′ may be placed a few feetaway from patient 12 and would still be within range to wirelesslycommunicate with telemetry antennas 28, 32 and 38.

The uplink to remote web-based expert data center 62, hereinafterreferred to as, interchangeably, “data center 62”, “expert data center62” or “web-based data center 62” without limitations, is accomplishedthrough programmer 20 or webtop unit 20′. Accordingly programmer 20 andwebtop unit 20′ function as an interface between IMDs 10, 10′ and 10″and data center 62. One of the many distinguishing elements of thepresent invention includes the use of various scalable, reliable andhigh-speed wireless communication systems to bi-directionally transmithigh fidelity digital/analog data between programmer 20 and data center62.

There are a variety of wireless mediums through which datacommunications could be established between programmer 20 or pilldispenser 20′ and data center 62. The communications link betweenProgrammer 20 or pill dispenser 20′ and data center 62 could be modem60, which is connected to programmer 20 on one side at line 63 and datacenter 62 at line 64 on the other side. In this case, data istransferred from data center 62 to programmer 20 via modem 60. Alternatedata transmission systems include, without limitations, stationarymicrowave and/or RF antennas 48 being wirelessly connected to programmer20 via tunable frequency wave delineated by line 50. Antenna 48 is incommunications with data center 62 via wireless link 65. Similarly, pilldispenser 20′, mobile vehicle 52 and satellite 56 are in communicationswith data center 62 via wireless link 65. Further, mobile system 52 andsatellite 56 are in wireless communications with programmer 20 or pilldispenser 20′ via tunable frequency waves 54 and 58, respectively.

In the preferred embodiment a Telnet system is used to wirelessly accessdata center 62. Telnet emulates a client/server model and requires thatthe client run a dedicated software to access data center 62. The Telnetscheme envisioned for use with the present invention includes variousoperating systems including UNIX, Macintosh, and all versions ofWindows.

Functionally, an operator at programmer 20 or an operator at data center62 would initiate remote contact. Programmer 20 is down linkable to IMDsvia link antennas 28, 32 and 38 to enable data reception andtransmission. For example, an operator or a clinician at data center 62may downlink to programmer 20 to perform a routine or a scheduledevaluation of programmer 20. In this case the wireless communication ismade via wireless link 65. If a downlink is required from programmer 20to IMD 10 for example, the downlink is effected using telemetry antenna22. In the alternate, if an uplink is initiated from patient 12 toprogrammer 20 the uplink is executed via wireless link 26. As discussedherein below, each antenna from the IMDs can be used to uplink all orone of the IMDs to programmer 20. For example, IMD 10, 10′, 10″ (whichrelates to neural implant 30) can be implemented to up-link, viawireless antenna 26′, 28′, 34′, 34′ 40, 40′ or wireless antenna 24 ofcellular phone 20′, any one, two or more IMDs to programmer 20.Preferably bluetooth chips, adopted to function within the body tooutside the body and also adopted to provide low current drain, areembedded in order to provide wireless and seamless connections 42, 44and 46 between IMDs 10, 10′ and 10″. The communication scheme isdesigned to be broadband compatible and capable of simultaneouslysupporting multiple information sets arid architecture, transmitting atrelatively high speed, to provide data, sound and video services ondemand.

FIG. 2 illustrates typical components of an IMD, such as thosecontemplated by the present invention. Specifically, major operativestructures common to all IMDs 10, 10′ and 10″ are represented in ageneric format. In the interest of brevity, IMD 10 relative to FIG. 2refers to all the other IMDs. Accordingly, IMD 10 is implanted inpatient 12 beneath the patient's skin or muscle and is electricallycoupled to heart 16 of patient 12 through pace/sense electrodes and leadconductor(s) (denoted by reference numeral 14 in FIG. 1) of at least onecardiac pacing lead 18 in a manner known in the art. IMD 10 containstherapy 1 monitor 70, timing control 72 including operating system thatmay employ microprocessor 74 or a digital state machine for timing,sensing and pacing functions in accordance with a programmed operatingmode. IMD 10 also contains sense amplifiers for detecting cardiacsignals, patient activity sensors or other physiologic sensors forsensing the need for cardiac output, and pulse generating outputcircuits for delivering pacing pulses to at least one heart chamber ofheart 16 under control of the operating system in a manner well known inthe prior art. The operating system includes memory registers or RAM/ROM78 for storing a variety of programmed-in operating mode and parametervalues that are used by the operating system. The memory registers orRAM/ROM 76 may also be used for storing data compiled from sensedcardiac activity and/or relating to device operating history or sensedphysiologic parameters for telemetry out on receipt of a retrieval orinterrogation instruction via suitable telemetry circuitry 78. All ofthese functions and operations are well known in the art, and many aregenerally employed to store operating commands and data for controllingdevice operation and for later retrieval to diagnose device function orpatient condition.

Programming commands or data are transmitted between IMD 10 RF telemetryantenna 28, for example, and an external RF telemetry antenna 24associated with programmer 20. In this case, it is not necessary thatthe external RF telemetry antenna 24 be contained in a programmer RFhead so that it can be located close to the patient's skin overlyingIMD10. Instead, the external RF telemetry antenna 24 can be located onthe case of programmer 20. It should be noted that programmer 20 can belocated some distance away from patient 12 and is locally placedproximate to the IMDs such that the communication between IMDs 10, 10′and 10″ and programmer 20 is telemetric. For example, programmer 20 andexternal RF telemetry antenna 24 may be on a stand a few meters or soaway from patient 12. Moreover, patient 12 may be active and could beexercising on a treadmill or the like during an uplink telemetryinterrogation of realtime ECG or other physiologic parameters.Programmer 20 may also be designed to universally program existing IMDsthat employ RF telemetry antennas of the prior art and therefore alsohave a conventional programmer RF head and associated software forselective use therewith.

In an uplink communication between IMD 10 and programmer 20, forexample, telemetry transmission 22 is activated to operate as atransmitter and external RF telemetry antenna 24 operates as a telemetryreceiver. In this manner data and information may be transmitted fromIMD10 to programmer 20. In the alternate, IMD 10 RF telemetry antenna 26operates as a telemetry receiver antenna to downlink data andinformation from programmer 20. Both RF telemetry antennas 22 and 26 arecoupled to a transceiver comprising a transmitter and a receiver.

FIG. 3A is a simplified circuit block diagram of major functionalcomponents of programmer 20. The external RF telemetry antenna 24 onprogrammer 20 is coupled to a telemetry transceiver 86 and antennadriver circuit board including a telemetry transmitter and telemetryreceiver 34. The telemetry transmitter and telemetry receiver arecoupled to control circuitry and registers operated under the control ofmicrocomputer 80. Similarly, within IMD 10, for example, the RFtelemetry antenna 26 is coupled to a telemetry transceiver comprising atelemetry transmitter and telemetry receiver. The telemetry transmitterand telemetry receiver in IMD 10 are coupled to control circuitry andregisters operated under the control of microcomputer 74.

Further referring to FIG. 3A, programmer 20 is a personal computer type,microprocessor-based device incorporating a central processing unit,which may be, for example, an Intel Pentium microprocessor or the like.A system bus interconnects CPU 80 with a hard disk drive, storingoperational programs and data, and with a graphics circuit and aninterface controller module. A floppy disk drive or a CD ROM drive isalso coupled to the bus and is accessible via a disk insertion slotwithin the housing of programmer 20. Programmer 20 further comprises aninterface module, which includes a digital circuit, a non-isolatedanalog circuit, and an isolated analog circuit. The digital circuitenables the interface module to communicate with interface controllermodule. Operation of the programmer in accordance with the presentinvention is controlled by microprocessor 80.

In order for the physician or other caregiver or operator to communicatewith the programmer 20, a keyboard or input 82 coupled to CPU 80 isoptionally provided. However the primary communications mode may bethrough graphics display screen of the well-known “touch sensitive” typecontrolled by a graphics circuit. A user of programmer 20 may interacttherewith through the use of a stylus, also coupled to a graphicscircuit, which is used to point to various locations on screen ordisplay 84 which display menu choices for selection by the user or analphanumeric keyboard for entering text or numbers and other symbols.Various touch-screen assemblies are known and commercially available.Display 84 and or the keyboard comprise means for entering commandsignals from the operator to initiate transmissions of downlink oruplink telemetry and to initiate and control telemetry sessions once atelemetry link with data center 62 or an implanted device has beenestablished. Display screen 84 is also used to display patient relateddata and menu choices and data entry fields used in entering the data inaccordance with the present invention as described below. Display screen84 also displays a variety of screens of telemetered out data orreal-time data. Display screen 84 may also display plinked event signalsas they are received and thereby serve as a means for enabling theoperator to timely review link-history and status.

Programmer 20 further comprises an interface module, which includesdigital circuit, non-isolated analog circuit, and isolated analogcircuit. The digital circuit enables the interface module to communicatewith the interface controller module. As indicated hereinabove, theoperation of programmer 20, in accordance with the present invention, iscontrolled by microprocessor 80. Programmer 20 is preferably of the typethat is disclosed in U.S. Pat. No. 5,345,362 to Winkler, which isincorporated by reference herein in its entirety.

Screen 84 may also display up-linked event signals when received andthereby serve as a means for enabling the operator of programmer 20 tocorrelate the receipt of uplink telemetry from an implanted device withthe application of a response-provoking action to the patient's body asneeded. Programmer 20 is also provided with a strip chart printer or thelike coupled to interface controller module so that a hard copy of apatient's ECG, EGM, marker channel of graphics displayed on the displayscreen can be generated.

As will be appreciated by those of ordinary skill in the art, it isoften desirable to provide a means for programmer 20 to adapt its modeof operation depending upon the type or generation of implanted medicaldevice to be programmed and to be compliant with the wirelesscommunications system through which data and information is transmittedbetween programmer 20 and data center 62.

FIG. 3B is an illustration of the major components of Wave unit 90utilizing laser technologies such as for example the WaveStar Optic AirUnit, manufactured by Lucent Technologies or equivalent. This embodimentmay be implemented for large data transfer at high speed in applicationsinvolving several programmers. The unit includes laser 92, transceiver94 and amplifier 96. A first wave unit 90 is installed at data center 62and a second unit is located proximate to programmer 20 or pilldispenser 20′. Data transmission between remote data center 62 andprogrammer unit 20 is executed via wave units 90. Typically, the firstwave unit 90 accepts data and splits it into unique wavelength fortransmission. The second wave unit recomposes the data back to itsoriginal form.

FIGS. 4A, 4B and 4C represent various views of pill dispenser unit 20′.The structure includes pill containers 100 that protrude upwards fromthe surface for pill or drug containment. The structure also includesupper metalized layer 102, superimposed on a plastic cover and lowermetalized layer 104 superimposed on a plastic cover. Piezoelectric film106 is disposed between the upper and the lower metalized layers.Further, microprocessor 108 is embedded between the upper and the lowerlayers. Telemetric antenna 110 is in electronic communications withmicroprocessor 108 and extends outward proximate therefrom.

Pill container 100 includes an indicator for the absence or presence ofa pill in containers 100. Pill dispenser unit 20′ is in preferablytelemetric or equivalent wireless communications with IMDs 10, 10′ and10″. In the alternate, pill dispenser unit 20′ is in data communicationswith programmer 20.

Referring to FIG. 5, a communication scheme between remote data center62, physician station 120 and programmer 20 and/or pill dispenser unit20′. As indicated hereinabove, data center 62 includes high-speedcomputers and is preferably web enabled to provide remote access.Communication links A, B, C, D, E and F are preferably wireless althoughany other communication system such as cable, fiber-optics or equivalentcould be implemented.

Generally, the present invention provides drug delivery and managementprimarily based on the chronic communications between pill dispenserunit 20′ and IMDs 10, 10′ and 10″. Specifically, IMDs 10, 10′ and 10″include a software program which would monitor the number of pills inpill dispenser 20′ via link B which is equivalent to telemetry 110. Inthe alternate, the number of pills in dispenser 20′ may be tracked vialink C which establishes the communication between pill dispenser 20′and programmer 20. Pill dispenser 20′ includes means for indicating thepill deposition from the package or container. Further IMDs 10, 10′ and10″ include means for monitoring the deposition of the pills. Aprescribed therapy schedule is preferably preprogrammed in the memory ofIMDs 10, 10′ and 10″. The actual pill deposition in container 100 isknown and correlates to one or more of the parameters programmed in IMDs10, 10′ and 10″. Thus, the actual pill removal is assumed to be aprecursor of administration of the pill by the patient consistent withthe prescribed regimen. The relevant marker designating the time,dosage, and the type of medication is generated within a variousdiagnostic tables, and trend curves representing different physiologicparameters.

Further, IMDs 10, 10′ and 10″ chronically monitor the physiologicparameters of the patient and may alert the patient in cases, forexample, when the drug does not influence a trend curve, causes thetrends curve to oscillate, patient is not following the prescribedregimen or patient stops taking the medication altogether. Subsequently,IMDs 10, 10′ and 10″ could alert the physician or clinician to conferwith the patient. This may be done via programmer 20 up-linking to datacenter 62. The Physician at station 120 will be able to access thepatient data from data center 62. As shown in FIG. 5, Pill dispenser 20′is in data communication with data center 62. Thus the status of pilldispenser 20′ is registered in either device or patient databases forthe clinician to investigate.

Pill dispenser 20′ is generally structured with a plurality of metal;liclayers such as 102 and 104, preferably aluminum and plastic layers. Thuspill dispenser 20′ is a capacitor cell. Piezoelectric film 106 issimilar to commercially available Kynar or equivalent, sandwithcedbetween the two layers. Accordingly, whenever the patient manipulatespill dispenser 20′ to break container 100 and remove a pill, a voltagewill be produced within the piezoelectric film. This voltage may be usedas a signal to the IMDs indicating the removal of a pill. Specifically,the signal being different from ECG, EMG, EMI or any other bodygenerated signal, is suited to be used as a signal from pill dispenser20′ to IMDs 10. 10′ and 10″. IMDs 10, 10′ and 10″ may be programmed toidentify this signal as an indication that the seal has been opened andthat a pill has been injested by the patient. In the alternate, pilldispenser 20′ may be used as a capacitor in a resonant circuit. Underthis approach, when the patient presses the pill dispenser 20′ theimpendance is changed due to the skin-metal impedance change andconsequently the resonanace circuit may be closed by the patient'shands. Accordingly, IMDs 10, 10′ and 10″ are able to monitor dose dataand related clinical parameters by communicating with pill dispenser20′. The measurements performed by IMDs 10, 10′ and 10″ are specific tothe type of preprogrammed criteria and determinants thereof. However, inthe context of the present invention, IMDs 10, 10′ and 10″ could beprogrammed to monitor a given pill dispenser 20′ on a chronic basis.This will provide a stream of data that will indicate whether thepatient has been following a prescribed dose and regimen. Further, IMDs10, 10′ and 10″ may be programmed to monitor the efficacy of the drug bymonitoring the physiological effects of the drug on the patient.Accordingly, a direct, real time assessment and interpretation ofclinical status is obtained under the communication scheme advanced bythe present invention.

Referring to programmer 20 in more detail, when a physician or anoperator needs to interact with programmer 20, a keyboard coupled toProcessor 80 is optionally employed. However the primary communicationmode may be through graphics display screen of the well-known “touchsensitive” type controlled by graphics circuit. A user of programmer 20may interact therewith through the use of a stylus, also coupled to agraphics circuit, which is used to point to various locations on ascreen/display to display menu choices for selection by the user or analphanumeric keyboard for entering text or numbers and other symbols asshown in the above-incorporated '362 patent. Various touch-screenassemblies are known and commercially available. The display and or thekeyboard of programmer 20, preferably include means for entering commandsignals from the operator to initiate transmissions of downlinktelemetry from IMDs and to initiate and control telemetry sessions oncea telemetry link with one or more IMDs has been established. Thegraphics display/screen is also used to display patient related data andmenu choices and data entry fields used in entering the data inaccordance with the present invention as described below. The graphicsdisplay/screen also displays a variety of screens of telemetered outdata or real-time data. Programmer 20 is also provided with a stripchart printer or the like coupled to interface controller module so thata hard copy of a patient's ECG, EGM, marker channel or similar graphicsdisplay can be generated. Further, Programmer 20's history relating toinstrumentation and software status may be printed from the printer.Similarly, once an uplink is established between programmer 20 and anyone of IMDs 10, 10′ and 10″, various patient history data and IMDperformance data may be printed out. The IMDs contemplated by thepresent invention include a cardiac pacemaker, a defibrillator, apacer-defibrillator, implantable monitor (Reveal), cardiac assistdevice, and similar implantable devices for cardiac rhythm and therapy.Further the IMD units contemplated by the present invention includeelectrical stimulators such as, but not limited to, a drug deliverysystem, a neural stimulator, a neural implant, a nerve or musclestimulator or any other implant designed to provide physiologicassistance or clinical therapy.

Data center 62 represents a high speed computer network system havingwireless bi-directional data, voice and video communications withprogrammer 20 and/or pill dispenser 20′ via wireless communications link136. Generally data center 62 is preferably located in a centrallocation and is preferably equipped with high-speed web-based computernetworks. Preferably, data center 24 is manned 24-hours by operators andclinical personnel who are trained to provide a web-based remote serviceto programmer 20 and/or pill dispenser 20′. In accordance with thepresent invention, data center may be located in a corporateheadquarters or manufacturing plant of the company that manufacturesprogrammer 20. The wireless data communications link/connections can beone of a variety of links or interfaces, such as a local area network(LAN), an internet connection, a telephone line connection, a satelliteconnection, a global positioning system (GPS) connection, a cellularconnection, a laser wave generator system, any combination thereof, orequivalent data communications links.

As stated hereinabove, bidirectional wireless communications D , E and Fact as a direct conduit for information exchange between remote datacenter 62 and programmer 20, pill dispenser 20′ and physician center120, respectively. Further, bi-directional wireless communications A andB provide an indirect link between remote data center 62 and IMDs 10,10′ and 10″ via programmer 20 and pill dispenser 20′. In the context ofthis disclosure the word “data” when used in conjunction withbi-directional wireless communications also refers to sound, video andinformation transfer between the various centers.

Generally, in the context of the invention, all programmers locatedproximate to IMDs or patients with IMDs and distributed globally areconnected to an expert data center to share software upgrades and accessarchived data. The programmer functions as an interface between theremotely located expert data center and the IMDs. Further, proceduralfunctions such as monitoring the performance of the IMDs, upgradingsoftware in the IMDs, upkeep and maintenance of the IMDS and relatedfunctions are implemented via the programmer. The preferably telemetricand yet local interaction between the programmer and the IMDs needs tobe managed by a qualified operator. In order to facilitate thejust-in-time patient care at the location of the patient, the inventionprovides pill dispenser 20′ that is preferably wirelessly linked to datacenter 62. This scheme enables the dissemination of drug relatedclinical information worldwide while maintaining a high standard ofpatient care at reduced costs.

Although specific embodiments of the invention have been set forthherein in some detail, it is understood that this has been done for thepurposes of illustration only and is not to be taken as a limitation onthe scope of the invention as defined in the appended claims. It is tobe understood that various alterations, substitutions, and modificationsmay be made to the embodiment described herein without departing fromthe spirit and scope of the appended claims.

What is claimed is:
 1. A drug delivery and management system in chroniccommunication between a pill dispenser and at least one implantedmedical device (IMD) comprising: means for monitoring the number ofpills in a pill dispenser; means for indicating pill deposition from acontainer in said pill dispenser; means for monitoring the deposition ofthe pills incorporated in an implanted medical device; means forpreprogramming a drug therapy regimen implemented in said implantedmedical device; and means for chronically monitoring and alerting apatient when said drug does not influence a trend curve.
 2. The systemof claim 1 wherein said means for monitoring the number of pillsincludes a microprocessor.
 3. The system of claim 2 wherein said meansfor monitoring the number of pills further includes a telemetric antennain communication with said microprocessor.
 4. The system of claim 1wherein said means for indicating pill deposition includes apiezoelectric film.
 5. The system of claim 1 wherein one of a voltagesignal and impedance change is used to monitor the number of pills inthe pill dispenser.
 6. A capacitor cell forming a pill dispenser havingwireless communication between at least one implanted medical device andexternal devices, including a remote database center, the combinationcomprising: the pill dispenser having a piezoelectric film; means forsensing breakage of a container incorporated in said capacitor cell;means for producing a signal when a pill is removed from the pilldispenser, said signal being different from ECG, EMG, EMR or otherbody-generated signal; means for identifying the signal as an indicationthat a seal has been opened and that a pill has been ingested by apatient; and means for chronically monitoring the pill dispenser inconjunction with the patient's physiological data and reaction thereof.7. The combination of claim 6 wherein said means for sensing breakageincludes one of a voltage signal and impedance change to sense breakageof a container.
 8. The combination of claim 6 wherein said means forproducing a signal when a pill is removed from said container includesmeans for confirming breakage of a layer.
 9. The combination of claim 7wherein said means for sensing breakage includes means for transferringa signal to the at least one implanted medical device to trigger a timerto monitor pill ingestion by the patient.